1. Field of the Invention
The present invention relates generally to storage containers for pharmaceuticals, and specifically to temperature-controlled storage containers for pharmaceuticals.
2. Description of Prior Art
Most pharmaceutical substances, such as epinephrine, diazepam, and naloxone are temperature sensitive, and will undergo chemical alteration, will lose potency or have a diminished shelf life if exposed to temperatures over or under the manufacturers' required temperature storage range. This temperature storage range is typically 15-30 degrees Celsius (59-86 degrees Fahrenheit) and is described by the U. S. Pharmacopoeia as "room temperature".
The danger of administering a drug that has been chemically altered or that has lost potency is that the drug will not have the anticipated efficacy. A paramedic who is ignorant of the condition of a temperature affected drug may use it in a life threatening situation, relying on the drug to save the patient's life. Some pharmaceutical substances can even become toxic if exposed to high or low temperatures.
In hospital environments wherein the temperature is controlled, pharmaceuticals are easily maintained within the required temperature range. But in pre-hospital situations, such as are found on ambulances and helicopters, pharmaceuticals are commonly exposed to temperatures outside of the required temperature range. There are 23 common pharmaceuticals that are carried by paramedics nationwide. These and other pharmaceuticals that are carried by paramedics are required to be maintained at room temperature. However, these pharmaceuticals are exposed to temperatures in excess of 100 degrees in the summertime in southern and southwestern locations and to subfreezing temperatures in northern locations. Thus, the temperature requirement for pre-hospital pharmaceuticals has long been overlooked and even ignored.
Each year, some 20 million people are cared for in a pre-hospital setting (such as by paramedics). Of these, about 5 million people, according to industry estimates, are provided with advanced life support in an effort to prevent death. The advanced life support includes the administration of pharmaceuticals. Thus, each year millions of people are exposed to the hazards of pharmaceuticals that have been exposed to temperature extremes.
Besides loss of pharmaceutical efficacy, administering drugs that are too hot or cold can cause severe metabolic harm in emergency medical patients. For example, in the winter, paramedics are frequently faced with the problem of administering cold solutions intravenously. Such practices could send the patient into hypothermic shock, resulting in death. Thus, there is a real need to maintain temperature sensitive pharmaceutical and diagnostic substances within the required temperature range.
In the prior art, there is Launius, U.S. Pat. No. 3,858,106. Launius provides a battery powered system for maintaining insulin within the refrigerated temperature range of 40-55 degrees Fahrenheit. This is below room temperature range. Paramedics do not typically carry insulin when providing pre-hospital care. They carry sugar instead. Because the Launius apparatus is battery powered, it is possible for loss of power to occur, thereby resulting in an inability to maintain the designated temperature range and undermining the potency or shelf life of the pharmaceutical substance. For example, the battery can be drained if any door or port to the storage device is inadvertently left ajar. Launius does not provide any mechanism to warn of such problems.
The physicians, nurses and allied health personnel charged with transporting and using pharmaceutical or diagnostic substances have no way of evaluating if the pharmaceutical or diagnostic substance has been permanently damaged, short of expensive chemical testing. This is particularly true where the substances are carried on board ambulances, helicopters or other mobile units. For purposes of this application, the term "pharmaceutical substance" includes diagnostic substances as well as pharmaceutical substances.
Devastating legal liabilities can be incurred if a physician, nurse or medical technician administers pharmaceuticals that have a diminished or lost efficacy. Known temperature-controlled pharmaceutical storage devices offer the physician, nurse or medical technician no assistance in detecting and preventing such an error.
It is one objective of the present invention to provide a temperature-controlled pharmaceutical storage device which maintains pharmaceutical substances between required room temperature (15-30 degrees Celsius) boundaries, and which detects and warns when temperature violations have occurred which have possibly diminished the efficacy of the pharmaceutical substance.
It is another object of the preferred embodiment to provide a temperature controlled pharmaceutical storage device which prevents the unauthorized resetting of the temperature violation indication, provides a backup power supply to power the indicator and provides impact protection to the pharmaceutical containers located therein.
It is another objective of the present invention to provide a temperature-controlled pharmaceutical storage device which automatically disables the heating and cooling means when the storage container is opened, to preserve the storage device battery.
It is still another objective of the present invention to provide a temperature-controlled pharmaceutical storage device which includes a means for draining and absorbing condensate resulting from disparate interior and exterior temperatures.